ID

36039

Beschreibung

A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004); ODM derived from: https://clinicaltrials.gov/show/NCT02461563

Link

https://clinicaltrials.gov/show/NCT02461563

Stichworte

Versionen (1)
  1. 10.04.19 10.04.19 -
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See clinicaltrials.gov

Hochgeladen am

10. April 2019

DOI

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Eligibility Hepatitis C Virus Infection NCT02461563

Englisch

Eligibility Hepatitis C Virus Infection NCT02461563

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female of non-childbearing potential
Beschreibung

Gender Childbearing Potential Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
have a body mass index (bmi) >=18 to =< 37 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
excepting hcv infection, be in good health
Beschreibung

Exception Hepatitis C | Good health

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C3813622
have a clinical diagnosis of chronic hcv infection, exclusively gt1 or exclusively gt3
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
agree to follow smoking restrictions
Beschreibung

Tobacco use Restriction Agree

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C3641827
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of clinically significant, not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
Beschreibung

Endocrine System Diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Cardiovascular Diseases Poorly controlled | Hematological Disease Poorly controlled | Liver diseases Poorly controlled | Immune System Diseases Poorly controlled | Kidney Diseases Poorly controlled | Respiration Disorders Poorly controlled | Disorder of the genitourinary system Poorly controlled | Nervous system disorder Major Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C3853134
UMLS CUI [6,1]
C0021053
UMLS CUI [6,2]
C3853134
UMLS CUI [7,1]
C0022658
UMLS CUI [7,2]
C3853134
UMLS CUI [8,1]
C0035204
UMLS CUI [8,2]
C3853134
UMLS CUI [9,1]
C0080276
UMLS CUI [9,2]
C3853134
UMLS CUI [10,1]
C0027765
UMLS CUI [10,2]
C0205164
UMLS CUI [10,3]
C3853134
have been treated with amiodarone within the prior year, or is currently on beta-blockers or verapamil
Beschreibung

Amiodarone | Adrenergic beta-Antagonists | Verapamil

Datentyp

boolean

Alias
UMLS CUI [1]
C0002598
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0042523
has a history of cancer (malignancy)
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Beschreibung

Multiple allergies | Severe allergy | Food Allergy | Drug Allergy | Latex allergy | Anaphylaxis Pharmaceutical Preparations | Intolerance to Pharmaceutical Preparations | Anaphylaxis Non-Prescription Drugs | Intolerance to Non-Prescription Drugs | Anaphylaxis Food | Intolerance to Food

Datentyp

boolean

Alias
UMLS CUI [1]
C0740281
UMLS CUI [2]
C2945656
UMLS CUI [3]
C0016470
UMLS CUI [4]
C0013182
UMLS CUI [5]
C0577628
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0013227
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0013227
UMLS CUI [8,1]
C0002792
UMLS CUI [8,2]
C0013231
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0013231
UMLS CUI [10,1]
C0002792
UMLS CUI [10,2]
C0016452
UMLS CUI [11,1]
C1744706
UMLS CUI [11,2]
C0016452
is positive for hepatitis b surface antigen or human immunodeficiency virus (hiv)
Beschreibung

Hepatitis B surface antigen positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019699
has had major surgery, donated or lost approximately 500 ml blood within 4 weeks prior to screening visit
Beschreibung

Major surgery | Blood Donation Amount | Blood Loss Amount

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C1265611
has participated in another drug trial within 4 weeks prior to screening visit
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
is taking a non-permitted medication to treat a co-morbid condition
Beschreibung

Illicit medication use Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0009488
consumes greater than 2 glasses of alcoholic beverages
Beschreibung

Alcohol consumption Drinks Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C1265611
is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
Beschreibung

Cannabis use Regular | Illicit drug use | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3160814
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0038586
has evidence or history of chronic hepatitis not caused by hcv, including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, or autoimmune hepatitis
Beschreibung

Hepatitis C, Chronic | Etiology Absent HCV | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune

Datentyp

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C0042721
UMLS CUI [4]
C3241937
UMLS CUI [5]
C1262760
UMLS CUI [6]
C0241910
has been treated with other hcv inhibitors, such as sofosbuvir or vx-135
Beschreibung

HCV inhibitors | sofosbuvir | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0243077
UMLS CUI [2]
C2976303
UMLS CUI [3]
C3846158
has evidence of advanced or decompensated liver disease, bridging fibrosis or higher grade fibrosis from a prior liver biopsy
Beschreibung

Liver disease Advanced | Decompensated liver disease | Bridging fibrosis | Fibrosis Severe Biopsy of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C4075847
UMLS CUI [3]
C0334160
UMLS CUI [4,1]
C0016059
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0193388
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Ähnliche Modelle

Eligibility Hepatitis C Virus Infection NCT02461563

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender Childbearing Potential Absent
Item
female of non-childbearing potential
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Body mass index
Item
have a body mass index (bmi) >=18 to =< 37 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Exception Hepatitis C | Good health
Item
excepting hcv infection, be in good health
boolean
C1705847 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2])
Chronic Hepatitis C Genotype
Item
have a clinical diagnosis of chronic hcv infection, exclusively gt1 or exclusively gt3
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Tobacco use Restriction Agree
Item
agree to follow smoking restrictions
boolean
C0543414 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Endocrine System Diseases Poorly controlled | Gastrointestinal Diseases Poorly controlled | Cardiovascular Diseases Poorly controlled | Hematological Disease Poorly controlled | Liver diseases Poorly controlled | Immune System Diseases Poorly controlled | Kidney Diseases Poorly controlled | Respiration Disorders Poorly controlled | Disorder of the genitourinary system Poorly controlled | Nervous system disorder Major Poorly controlled
Item
has a history of clinically significant, not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
boolean
C0014130 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0021053 (UMLS CUI [6,1])
C3853134 (UMLS CUI [6,2])
C0022658 (UMLS CUI [7,1])
C3853134 (UMLS CUI [7,2])
C0035204 (UMLS CUI [8,1])
C3853134 (UMLS CUI [8,2])
C0080276 (UMLS CUI [9,1])
C3853134 (UMLS CUI [9,2])
C0027765 (UMLS CUI [10,1])
C0205164 (UMLS CUI [10,2])
C3853134 (UMLS CUI [10,3])
Amiodarone | Adrenergic beta-Antagonists | Verapamil
Item
have been treated with amiodarone within the prior year, or is currently on beta-blockers or verapamil
boolean
C0002598 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
C0042523 (UMLS CUI [3])
Malignant Neoplasms
Item
has a history of cancer (malignancy)
boolean
C0006826 (UMLS CUI [1])
Multiple allergies | Severe allergy | Food Allergy | Drug Allergy | Latex allergy | Anaphylaxis Pharmaceutical Preparations | Intolerance to Pharmaceutical Preparations | Anaphylaxis Non-Prescription Drugs | Intolerance to Non-Prescription Drugs | Anaphylaxis Food | Intolerance to Food
Item
has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
boolean
C0740281 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0016470 (UMLS CUI [3])
C0013182 (UMLS CUI [4])
C0577628 (UMLS CUI [5])
C0002792 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C0002792 (UMLS CUI [8,1])
C0013231 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0013231 (UMLS CUI [9,2])
C0002792 (UMLS CUI [10,1])
C0016452 (UMLS CUI [10,2])
C1744706 (UMLS CUI [11,1])
C0016452 (UMLS CUI [11,2])
Hepatitis B surface antigen positive | HIV Seropositivity
Item
is positive for hepatitis b surface antigen or human immunodeficiency virus (hiv)
boolean
C0149709 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Major surgery | Blood Donation Amount | Blood Loss Amount
Item
has had major surgery, donated or lost approximately 500 ml blood within 4 weeks prior to screening visit
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
has participated in another drug trial within 4 weeks prior to screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Illicit medication use Comorbidity
Item
is taking a non-permitted medication to treat a co-morbid condition
boolean
C0281875 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Alcohol consumption Drinks Quantity
Item
consumes greater than 2 glasses of alcoholic beverages
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Cannabis use Regular | Illicit drug use | Substance Use Disorders
Item
is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
boolean
C3160814 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0281875 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Hepatitis C, Chronic | Etiology Absent HCV | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Hepatitis, Autoimmune
Item
has evidence or history of chronic hepatitis not caused by hcv, including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, or autoimmune hepatitis
boolean
C0524910 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0042721 (UMLS CUI [3])
C3241937 (UMLS CUI [4])
C1262760 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
HCV inhibitors | sofosbuvir | Other Coding
Item
has been treated with other hcv inhibitors, such as sofosbuvir or vx-135
boolean
C0220847 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
C2976303 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Liver disease Advanced | Decompensated liver disease | Bridging fibrosis | Fibrosis Severe Biopsy of liver
Item
has evidence of advanced or decompensated liver disease, bridging fibrosis or higher grade fibrosis from a prior liver biopsy
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
C0334160 (UMLS CUI [3])
C0016059 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
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